Written and maintained by CASRAI Editorial Board
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General product and regulatory information for lab, clinic and supply staff. This page is not medical advice and does not describe how to treat or close any wound; ask a clinician about an injury.
Short answer
A butterfly closure is an adhesive skin closure strip: a thin strip coated on one side with adhesive that holds the edges of a small wound together. Under US rules it is a Class I medical device, exempt from 510(k) premarket notification, filed under FDA product code FPX, “strip, adhesive, closure, skin.” “Butterfly bandage,” “butterfly closure” and “Steri-Strips” are everyday names for the same device family.
Definition and scope
FDA regulates these strips under 21 CFR 880.5240, “Medical adhesive tape and adhesive bandage.” The regulation identifies the device as a strip of fabric or plastic coated on one side with adhesive, which may include a surgical dressing pad without a disinfectant. Its listed uses are to cover and protect wounds, to hold the skin edges of a wound together, to support an injured body part, or to secure objects to the skin.
That wording is why “closure” appears in the product name: holding skin edges together is one of the uses the regulation itself names. The same regulation also covers ordinary adhesive bandages and medical tape, so a closure strip is one product within a broader regulated category rather than a category of its own.
How it is used in practice
Cleveland Clinic describes butterfly bandages and Steri-Strips as adhesive strips that hold the edges of a small cut together, and notes that people often use the two terms interchangeably. Application and removal depend on the product and the wound, so they belong to a clinician or the manufacturer’s instructions for use, not to a general reference page. For supply staff, the practical point is that the label on the box, not the nickname, identifies what a product is.
Names and related terms
Because one device goes by several names, catalogue searches and purchasing requests can disagree on wording. This cross-walk lists each name, what it means, and where that meaning comes from.
| Name | What it refers to | Source |
|---|---|---|
| Skin closure strip | Descriptive everyday name for an adhesive strip that holds skin edges together | 21 CFR 880.5240 (wording of the identification) |
| “Strip, adhesive, closure, skin” | FDA’s device name for product code FPX; Class 1, 510(k) exempt, regulation 880.5240 | FDA Product Classification database |
| Steri-Strips | Strips of uniform width, per Cleveland Clinic; often used interchangeably with “butterfly bandage” | Cleveland Clinic |
| Butterfly bandage / butterfly closure | Strips with wider ends that narrow at the centre, per Cleveland Clinic | Cleveland Clinic |
| Butterfly stitches | A surgical sewing technique, distinct from adhesive strips | Cleveland Clinic |
| Butterfly needle | An unrelated device used for blood draws; see the butterfly needle guide | CASRAI guide |
Types of closure strips
The type distinction Cleveland Clinic draws is shape: uniform-width strips (Steri-Strips) versus butterfly-shaped strips with wider ends, as Cleveland Clinic describes them. Other variations between products, such as size, reinforcement and sterile packaging, are set by each manufacturer and appear on its labelling.
Where it matters for labs, clinics and supply decisions
- Regulatory class. Class I with general controls and a 510(k) exemption (subject to the limitations in 21 CFR 880.9). The product code record is a category entry; it does not describe the sterility or contents of any individual product.
- Same family, different wording. Product code FPX and regulation 880.5240 give a neutral reference point when a request says “butterfly closure” and a catalogue says “skin closure strip.”
- Adjacent categories. Closure strips sit beside bandages and medical tape in the same regulation. For how sterile status affects supply decisions, see the sterile vs non-sterile purchasing guide.
Common misunderstandings
“Butterfly stitches” are not stitches
Cleveland Clinic separates the surgical sewing technique called butterfly stitches from adhesive strips. A closure strip involves no thread.
A butterfly closure is not a butterfly needle
The two share an insect name and nothing else. The needle is a blood-collection device; the closure is an adhesive strip.
A closure strip is not a replacement for a suture
CASRAI’s suture guide treats adhesive closure strips as light surface support rather than a standalone alternative to sutures. Whether a given wound needs strips, stitches or neither is a clinical decision for a clinician.
“Class I” does not mean “sterile”
The class describes regulatory controls on the device type. It says nothing about whether a particular box is sterile; the product labelling does.
FAQ
What is a butterfly bandage?
A butterfly bandage is an adhesive strip with wider ends that narrow at the centre, used to hold the edges of a small wound together. It belongs to the same device family FDA files as “strip, adhesive, closure, skin” (product code FPX).
Are Steri-Strips and butterfly bandages the same thing?
Cleveland Clinic notes that people often use the terms interchangeably. It distinguishes them by shape: Steri-Strips are uniform in width, while butterfly bandages have wider ends.
What are the types of Steri-Strips and skin closure strips?
The distinction a source supports is shape, uniform-width versus butterfly. Specific sizes and constructions vary by manufacturer and are stated on each product’s labelling.
Sources
- eCFR, 21 CFR 880.5240, Medical adhesive tape and adhesive bandage, checked 2026-10-30.
- FDA, Product Classification database, product code FPX, checked 2026-10-30.
- Cleveland Clinic, Steri-Strips and butterfly bandages, checked 2026-10-30.
